preview of best practices in study feasibility

BEST PRACTICESIN STUDY FEASIBILITY A U G U S T , 2 0 1 6

P R E V I E W O F

BEST PRACTICES IN

REPORT OVERVIEW

WHAT YOU WILL LEARN

How you can use this report

One of the primary challenges to successfully completing a clinical study is estimating the medical, clinical, logistical, and regulatory feasibility of the trial. Within the clinical trial feasibility process, sponsors, CROs and sites evaluate the possibility of conducting a clinical trial within a specific geographic region with the overall objective of completing the project with targeted patients and within defined timelines and costs. Thorough feasibility analyses that implement best practices will assist sponsors in delivering successful site start-ups and trials with data from the right patients while finishing on-time and on-budget. ISR gathered opinions from key stakeholders—sponsors, CROs and sites—to identify the best practices within the feasibility analysis process.

D A T A C O L L E C T I O N I N Q 1 , 2 0 1 6

2 0 - M I N U T E W E B - B A S E D

S U R V E Y

1 0 1 R E S P O N D E N T S F R O M S P O N S O R S , C R O S A N D S I T E S

106 PAGES

94 CHARTS AND

GRAPHS

VALUABLE FOR

• The percentage of trials that require a feasibility analysis and whether the analysis is conducted in-house or outsourced

• Objectives for conducting a feasibility analysis, the data sources utilized and site selection strategies

• Awareness of feasibility analysis service providers, frequency of use and how well providers performed with respect to client expectations

• Implement the top techniques and innovations identified by sponsors and CROs for conducting a feasibility analysis

• Improve the accuracy of your own feasibility analyses by learning which characteristics and activities contribute to a predictive feasibility estimate

• Understand the potential value to be gained by engaging a specialized feasibility analysis firm under specific circumstances

FOR PHARMA

FOR SERVICE PROVIDERS

Compare feasibility analysis practices with industry peers to identify areas to improve the accuracy of internal and/or outsourced estimations as well as satisfaction with service providers

Refine your company’s approach to conducting feasibility analyses by implementing the top techniques, innovations and best practices identified by the industry

Introduction

SMARTER QUESTIONS SMARTER ANSWERS

Full Table of Contents on next page.

MAJOR SECTIONS:1. Facilitators & Barriers to

Feasibility Analysis Success

2. Specialized Feasibility Analysis Firms Market Overview

3. Feasibility Analysis Service Provider Performance

4. Study Data

CLINICAL DEVELOPMENT

EXECUTIVE MANAGEMENT

INVESTIGATORS & SITE MANAGERS

THERAPEUTIC AREA HEADS

SITE RESEARCH COORDINATORS

SITE PRINCIPAL INVESTIGATORS

FEASIBILITY OR SITE SELECTION

CLINICAL OPERATIONS

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Introduction


TABLE OF CONTENTSCOPYRIGHT AND USAGE GUIDE

INTRODUCTION

METHODOLOGY

FACILITATORS & BARRIERS TO FEASIBILITY ANALYSIS SUCCESS

Primary Findings

Objectives when conducting a feasibility analysis

Consistency of industry’s feasibility analysis process

Use of feasibility analysis SOPs

Feasibility analysis site selection strategies

Characteristics of a predictive or accurate feasibility estimate – unprompted

Tracking the accuracy of in-house feasibility estimates

Accuracy of feasibility estimates from CROs, sites, and specialized firms

Sponsors

Improving feasibility estimates and analysis

Top techniques or innovations for feasibility analyses

Data sources for in-house feasibility analyses

Sponsors

CROs

Sites

Preferred data sources when using a service provider for feasibility analysis

Sponsors

SPECIALIZED FEASIBILITY ANALYSIS FIRMS MARKET OVERVIEW

Primary Findings

Circumstances for contracting a specialized feasibility firm – unprompted

Sponsors

CROs

Specialized feasibility firm differentiators – unprompted

Sponsors

FEASIBILITY ANALYSIS SERVICE PROVIDER PERFORMANCE

Primary Findings

Sponsors’ use of feasibility analyses

Awareness of feasibility analysis service providers

Sponsors

CROs

Feasibility analysis service provider use

Sponsors

CROs

Opinion of in-house feasibility analysis capabilities

Feasibility analysis service provider performance

Sponsors

CROs

STUDY DATA

Feasibility analysis objectives

Sponsors

CROs

Characteristics of a predictive or accurate feasibility estimate – unprompted

Sponsors

CROs

Sites

Consistency of industry’s feasibility analysis process

Sponsors

CROs

Sites

SOPs for conducting a feasibility analysis

Tracking the accuracy of in-house feasibility estimates

Feasibility estimate accuracy

Sponsors

Percentage of trials that require a feasibility analysis

Sponsors

Use of outside service providers for feasibility analysis

Sponsors

Conduct internal feasibility analysis when outsourcing

Sponsors

Conduct internal feasibility analysis when using in-house development resources

Sponsors

Data sources for in-house feasibility analysis

Sponsors

CROs

Sites

Barriers to using EMR data for feasibility estimates – unprompted

Sponsors

CROs

Sites

Preferred data sources when using a service provider for feasibility analysis

Sponsors

Opinion of in-house feasibility analysis capabilities

Sponsors

CROs

Sites

Utilization of investigators or coordinators when developing protocols

Sponsors

CROs


Introduction


94CHARTS

AND GRAPHS

SAMPLE PAGES

TABLE OF CONTENTSSite selection strategy for feasibility analysis

Sponsors

CROs

Pre-determined site criteria – unprompted

Sponsors

CROs

Ranking data sources’ impact on accuracy

Sponsors

CROs

Sites

Circumstances for contracting a specialized feasibility firm – unprompted

Sponsors

CROs

Specialized feasibility firm differentiators – unprompted

Sponsors

CROs

Room for improvement in CRO and sponsor feasibility processes

Sites

Characteristics of different and more effective feasibility processes – unprompted

Sponsors

CROs

Sites

Feasibility estimate challenges

Sponsors

CROs

Sites

Challenges impact on feasibility estimate accuracy in ranked order

Sponsors

CROs

Sites

Confidence in feasibility estimates

Sponsors

CROs

Sites

Desired improvements to feasibility estimates – unprompted

Sites

Best techniques and innovations for feasibility analysis – unprompted

Sponsors

CROs

Awareness of service providers’ feasibility analysis capabilities

Sponsors

CROs

Feasibility analysis service provider use

Sponsors

CROs

Feasibility analysis service provider performance

Sponsors

CROs

RESPONDENT PROFILE

Organization Type

Responsibilities

Interaction with functions

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Introduction


Introduction


11www.ISRreports.com ©2016 Best Practices in Study Feasibility

BEST PRACTICES IN STUDY FEASIBILITY

9

Objectives when conducting a feasibility analysis Every component of the analysis has an underlying objective designed to answer the question, “What decisions will sponsors, CROs, or sites be able to make once the analysis is complete?” Sponsors and CROs differ on what they see as the primary objective underlying a feasibility analysis. Sponsors cite Determine patient recruitment timelines most often as the primary objective (38%). CROs, however, point to Test the protocol achievability as the primary objective (45%). In other words, having designed a protocol and having confidence that protocol can and will be executed, sponsors want to know how long the patient recruitment process will take. CROs, on the other hand, want to determine whether a study using the sponsor’s protocol can be successfully completed. “What are your objective(s) when conducting a feasibility analysis, by which we mean the process by which a clinical study sponsor or clinical research organization can forecast and manage the number of patients per site per month for a specific protocol and determine realistic parameters for site enrollment months? Please select all that apply.” (Sponsors n=60, CROs n=20) “What is your primary objective when conducting a feasibility analysis? Please select one.” (Sponsors n=60, CROs n=20)

45%

48%

80%

88%

80%

72%

95%

87%

7%

35%

27%

45%

28%

20%

38%

0% 20% 40% 60% 80% 100%

CROs -Determine patient recruitment budget

Sponsors - Determine patient recruitment budget

CROs - Identify sites for inclusion in the study

Sponsors - Identify sites for inclusion in the study

CROs - Test the protocol achievability

Sponsors - Test the protocol achievability

CROs - Determine patient recruitment timelines

Sponsors - Determine patient recruitment timelines

% of Respondents

Primary Objective Objectives

Objectives when conducting a feasibility analysisEvery component of the analysis has an underlying objective designed to answer the question, “What decisions will sponsors, CROs, or sites be able to make once the analysis is complete?” Sponsors and CROs differ on what they see as the primary objective underlying a feasibility analysis� Sponsors cite Determine patient recruitment timelines most often as the primary objective (38%)� CROs, however, point to Test the protocol achievability as the primary objective (45%)� In other words, having designed a protocol and having confidence that protocol can and will be executed, sponsors want to know how long the patient recruitment process will take� CROs, on the other hand, want to determine whether a study using the sponsor’s protocol can be successfully completed� “What are your objective(s) when conducting a feasibility analysis, by which we mean the process by which a

clinical study sponsor or clinical research organization can forecast and manage the number of patients per site

per month for a specific protocol and determine realistic parameters for site enrollment months? Please select all

that apply.” (Sponsors n=60, CROs n=20)

“What is your primary objective when conducting a feasibility analysis? Please select one.” (Sponsors n=60, CROs

n=20)

© Industry Standard Research

This is an enterprise-wide license and this file is not to be distributed beyond the terms of this agreement. For information on the license holder, please contact ISR ([email protected]).

S A M P L E P A G E :

FEASIBILITY ANALYSIS OBJECTIVES

Sponsors and CROs differ on what they see as the primary objective underlying feasibility analysis.

C L O S E R L O O K

<< CROs are more likely than sponsors to state the primary objective of a feasibility study is to Test the protocol achievability.

Data available in the full report, which can be found at:

www.ISRreports.com

Introduction




9

Objectives when conducting a feasibility analysis Every component of the analysis has an underlying objective designed to answer the question, “What decisions will sponsors, CROs, or sites be able to make once the analysis is complete?” Sponsors and CROs differ on what they see as the primary objective underlying a feasibility analysis. Sponsors cite Determine patient recruitment timelines most often as the primary objective (38%). CROs, however, point to Test the protocol achievability as the primary objective (45%). In other words, having designed a protocol and having confidence that protocol can and will be executed, sponsors want to know how long the patient recruitment process will take. CROs, on the other hand, want to determine whether a study using the sponsor’s protocol can be successfully completed. “What are your objective(s) when conducting a feasibility analysis, by which we mean the process by which a clinical study sponsor or clinical research organization can forecast and manage the number of patients per site per month for a specific protocol and determine realistic parameters for site enrollment months? Please select all that apply.” (Sponsors n=60, CROs n=20) “What is your primary objective when conducting a feasibility analysis? Please select one.” (Sponsors n=60, CROs n=20)

45%

48%

80%

88%

80%

72%

95%

87%

7%

35%

27%

45%

28%

20%

38%

0% 20% 40% 60% 80% 100%

CROs -Determine patient recruitment budget

Sponsors - Determine patient recruitment budget

CROs - Identify sites for inclusion in the study

Sponsors - Identify sites for inclusion in the study

CROs - Test the protocol achievability

Sponsors - Test the protocol achievability

CROs - Determine patient recruitment timelines

Sponsors - Determine patient recruitment timelines

% of Respondents

Primary Objective Objectives

Objectives when conducting a feasibility analysisEvery component of the analysis has an underlying objective designed to answer the question, “What decisions will sponsors, CROs, or sites be able to make once the analysis is complete?” Sponsors and CROs differ on what they see as the primary objective underlying a feasibility analysis� Sponsors cite Determine patient recruitment timelines most often as the primary objective (38%)� CROs, however, point to Test the protocol achievability as the primary objective (45%)� In other words, having designed a protocol and having confidence that protocol can and will be executed, sponsors want to know how long the patient recruitment process will take� CROs, on the other hand, want to determine whether a study using the sponsor’s protocol can be successfully completed� “What are your objective(s) when conducting a feasibility analysis, by which we mean the process by which a

clinical study sponsor or clinical research organization can forecast and manage the number of patients per site

per month for a specific protocol and determine realistic parameters for site enrollment months? Please select all

that apply.” (Sponsors n=60, CROs n=20)

“What is your primary objective when conducting a feasibility analysis? Please select one.” (Sponsors n=60, CROs

n=20)



D A T A I N F U L L R E P O R T





Introduction


Introduction



Characteristics of a predictive or accurate feasibility estimate – unpromptedSponsors report the most predictive and accurate feasibility estimates are driven by Prior results in similar clinical studies (45%)� CROs and sites mention this characteristic as well, but less often than having Clear and achievable inclusion and exclusion criteria (45% CROs and 43% sites) upon which to base the feasibility estimate� Furthermore, sites mention having a Clear and detailed protocol as the most predictive characteristic (48%)� “In your experience, what makes for a predictive or accurate feasibility estimate? This is one of the key questions

of the study. Please be as specific as possible in your answer. Thank you.”


13

Characteristics of a predictive or accurate feasibility estimate – unprompted Sponsors report the most predictive and accurate feasibility estimates are driven by Prior results in similar clinical studies (45%). CROs and sites mention this characteristic as well, but less often than having Clear and achievable inclusion and exclusion criteria (45% CROs and 43% sites) upon which to base the feasibility estimate. Furthermore, sites mention having a Clear and detailed protocol as the most predictive characteristic (48%). “In your experience, what makes for a predictive or accurate feasibility estimate? This is one of the key questions of the study. Please be as specific as possible in your answer. Thank you.”

17%

9%

13%

48%

43%

17%

20%

5%

20%

20%

10%

5%

25%

45%

40%

25%

2%

2%

2%

3%

5%

5%

8%

13%

22%

22%

27%

45%

0% 20% 40% 60% 80%

Viable network of clinical sites

Readily available patients/patient database

Planning for retention

Reasonable time/budget estimates

Local market knowledge

Discounting stated feasibility estimate

Discussions with KOLs, thought leaders

Quality of investigator(s) and staff (experienced, interested)

Clear and detailed protocol

Clear and achievable inclusion and exclusion criteria

Quality of responses to feasibilty questionnaire (evidence of serious interest, expertise, resources)

Prior results (with similar patient population, protocol, therapy area)

% of Respondents

Sponsors (n=60) CROs (n=20) Sites (n=23)




CHARACTERISTICS OF A PREDICTIVE OR ACCURATE FEASIBILITY ESTIMATE — UNPROMPTEDThis page shows which attributes and activities contribute to an accurate feasibility estimate from the perspective of sponsors, CROs and sites.

The full data is available in the report, which can be downloaded from www.ISRreports.com.



Introduction


Introduction

STUDY DATA



Sponsors“In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced?

Please be as specific as possible. Thank you.” (n=60)


88

Best techniques and innovations for feasibility analysis – unprompted Sponsors “In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced? Please be as specific as possible. Thank you.” (n=60)

2%

2%

2%

3%

3%

3%

3%

3%

5%

5%

7%

8%

17%

18%

22%

23%

0% 10% 20% 30%

Using social media to measure interest

Planning for patient retention

Build time in schedule for administrative/legal/recruiting delays

Tailoring feasibility analysis to the patient population

More attention to detail/accuracy when developing estimates

Establishing a preferred investigator network

Conducting patient chart reviews

Applying technology/software to improving feasibility studies

Using real-time data monitoring

Increased collaboration with investigators on protocol

Seek out input experienced investigators and sites coordinators

Improving feasibility survey (online, more specific information) and reporting

Greater use of EMR and other patient databases

Making direct, personal contact with investigators, sites to build better relationships

Integrate statistical modeling/knowledge of past performance into feasibility analyses

No innovations experienced

% of Respondents




BEST TECHNIQUES AND INNOVATIONS FOR FEASIBILITY ANALYSIS — UNPROMPTEDThis page shows unprompted responses from sponsors on the best techniques and innovations utilized in their experience with feasibility analysis.

The full data is available in the report, which can be downloaded from www.ISRreports.com.



















Introduction

STUDY DATA



Sponsors“In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced?

Please be as specific as possible. Thank you.” (n=60)


88

Best techniques and innovations for feasibility analysis – unprompted Sponsors “In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced? Please be as specific as possible. Thank you.” (n=60)

2%

2%

2%

3%

3%

3%

3%

3%

5%

5%

7%

8%

17%

18%

22%

23%

0% 10% 20% 30%

















% of Respondents




Introduction


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BYJOB

LEVEL

Director 46%

Manager 29%

C-level 13%

VP 10%

BYEXPERIENCE

IN YEARS

16-20 years 23%

11-15years24%

6-10 years 11%

3-5 years 5%

20+ years 37%

BYCOMPANY

TYPE

Other 6%

Sponsor 78%

CRO 6%

ResearchSite 10%

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preview of best practices in study feasibility

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